IGMPI India

FDA has recently demanded that 14 companies in the natural products industry cease distribution of supplements that contain a substance known as DMBA (1, 3-Dimethylbutylamine). Earlier this month the agency warned five companies to stop selling dietary supplements containing a stimulant known as beta-methylphenylethylamine, or BMPEA.DMBA and BMPEA are similar to 1, 3 -dimethylamylamine, or DMAA, which has already been banned by the FDA. AS these substances hadn't been studied in humans and was an analogue of another controversial ingredient that FDA has declared cannot be marketed in supplements so FDA issued warning letters to 14 companies using DMBA.

FDA also said that the substance had not been marketed before Oct. 15, 1994 and therefore didn't qualify as a grandfathered ingredient under the 1994 Dietary Supplement Health and Education Act (DSHEA).

The products also fail to meet either of two requirements that would exempt DMBA from its status as an adulterant, according to the warning letters. FDA said the substance wasn’t present in the food supply in a form that wasn't chemically altered; and the agency was not aware that it had received a new dietary ingredient (NDI) notification citing DMBA's history of use or other evidence of safety.

Warning letters were issued to the following companies: Vital Pharmaceuticals Inc.; Powder City LLC; Prime Nutrition; Beta Labs; Genomyx LLC; Lecheek Nutrition; Iron Forged Nutrition; Nutrex Research Inc. Blackstone Labs LL; Core Nutritionals LLC; RPM Nutrition LLC; Brand New Energy LLC; and DSEO LLC.

FDA warned it may take additional enforcement action without further notice if the “adulterated" products aren’t immediately taken off the market.

The FDA banned a stimulant known as ephedra in 2004. Since then, companies have tried to replace it with other stimulants purported to be natural.